{"id":117848,"date":"2022-04-20T18:30:49","date_gmt":"2022-04-20T15:30:49","guid":{"rendered":"https:\/\/www.tehnopol.ee\/?p=117848"},"modified":"2022-04-20T18:30:50","modified_gmt":"2022-04-20T15:30:50","slug":"what-to-keep-in-mind-when-creating-software-based-medical-devices","status":"publish","type":"post","link":"https:\/\/www.tehnopol.ee\/en\/what-to-keep-in-mind-when-creating-software-based-medical-devices\/","title":{"rendered":"What to keep in mind when creating software-based medical devices"},"content":{"rendered":"
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The Connected Health Cluster<\/a>, lead by Tehnopol, organised an e-seminar focused on regulatory changes pertaining to software-based medical devices. Law Firm Sorainen gave an overview of the changes, while Thorgate and SoftComply from Estonia and Cosylab from Slovakia shared their experiences. This was the first in a series of events dedicated to software-based medical devices and the requirements that apply to them to make it easier and clearer for companies to navigate this area.<\/strong><\/p>\n\n\n\n

Connected Health Cluster member Law Firm Sorainen<\/a> is committed to bringing clarity to law concerning medicine and helping companies resolve various issues more easily. Among other things, Sorainen advises companies on regulatory changes; their experts know the minimum requirements that must be met to apply for a software-based medical device. Lise-Lotte L\u00e4\u00e4ne, Head of Sorainen\u2019s Life Sciences & Healthcare sector, says that although regulatory changes include the clearest definition yet of what is considered a software-based medical device, there are still some grey areas.\u00a0<\/p>\n\n\n\n

\u201cFor example, we\u2019re now faced with the question of how to determine when a particular piece of software or a mobile app constitutes a medical device \u2013 especially in the case of so-called wellness apps. I\u2019m sure that at some point, we\u2019ll see relevant court decisions or specific Commission guidance that may clarify the matter,\u201d says L\u00e4\u00e4ne. In the meantime, she says, the definition should be interpreted more broadly \u2013 if a mobile app in some way predicts a condition of medical significance, it is more likely to be a medical device. L\u00e4\u00e4ne added that it is always possible to ask the Estonian Health Board about classification, and this has been done. The European Union has included a scheme on its website to help companies determine whether the solution they are creating constitutes a medical device.\u00a0<\/p>\n\n\n\n

Once its status as a medical device is clear, the real work begins. \u201cYou have to determine the risk class of the device, then move on to conformity assessment while taking into consideration the general obligations of a manufacturer, and finally, once you have gone through the gauntlet and got the C mark on the product, you have to remember surveillance,\u201d summarises L\u00e4\u00e4ne.\u00a0\u00a0<\/p>\n\n\n\n

Test, test and test again!<\/h2>\n\n\n\n

Connected Health Cluster member Thorgate<\/a>, which operates in the field of software development, has sufficient international experience in this field. For example, Thorgate has partnered with the US to create a HIPAA-compliant communication platform for exchanging information on organ donation. It helped launch Brain Twin, a digital headache diary, in Norway and also contributed to the creation of a cooperation platform for rare disease patients and doctors.\u00a0<\/p>\n\n\n\n

According to Thorgate\u2019s Quality Manager Karl \u00d5kva, continuously testing your solution is the most important thing to do because when it comes to healthcare solutions, any mistake can prove very significant. He recommends getting several stakeholders involved in the process and asking for their feedback on the prototype or minimum viable product (MVP). Stakeholder feedback helps develop the product, keeping in mind what users actually need.\u00a0<\/p>\n\n\n\n

Quality system set-up first, product development second<\/h2>\n\n\n\n

SoftComply offers both quality and risk management systems for companies operating in highly regulated sectors. According to SoftComply\u2019s Head of Customer Relations Monika Isak, companies developing medical products seemed to be behind a high barrier; SoftComply\u2019s aim was to lower this barrier or reduce the market obstruction.\u00a0<\/p>\n\n\n\n

Describing the process, Isak says that once a company has assessed its product and ascertained that it does indeed constitute a medical device, a quality system must be set up and certified. Only then can product development begin, which must be done in line with the requirements of said quality system. This is followed by the submission and approval of product documentation, post-marketing surveillance and change management. Isak admits that companies have to take into consideration many requirements throughout their time operating in the medical field.\u00a0<\/p>\n\n\n\n

The next workshop on medical devices and the regulations governing them is set to take place in the coming months. Keep an eye on the channels of Tehnopol and the Connected Health Cluster!<\/p>\n\n\n\n

The Connected Health Cluster led by Tehnopol Science and Business Park is Estonia\u2019s biggest healthcare tech community, uniting health service providers, health tech companies and all other key interest groups in the field. The cluster\u2019s support enables domestic cooperation projects and the export of health technological solutions to other countries. The activities of the cluster are co-financed by Enterprise Estonia.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

The Connected Health Cluster, lead by Tehnopol, organised an e-seminar focused on regulatory changes pertaining to software-based medical devices. Law Firm Sorainen gave an overview of the changes, while Thorgate and SoftComply from Estonia and Cosylab from Slovakia shared their experiences. This was the first in a series of events dedicated to software-based medical devices […]<\/p>\n","protected":false},"author":28,"featured_media":117012,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"_s2mail":"yes","footnotes":""},"categories":[17],"tags":[],"class_list":["post-117848","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.tehnopol.ee\/en\/wp-json\/wp\/v2\/posts\/117848","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.tehnopol.ee\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.tehnopol.ee\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.tehnopol.ee\/en\/wp-json\/wp\/v2\/users\/28"}],"replies":[{"embeddable":true,"href":"https:\/\/www.tehnopol.ee\/en\/wp-json\/wp\/v2\/comments?post=117848"}],"version-history":[{"count":1,"href":"https:\/\/www.tehnopol.ee\/en\/wp-json\/wp\/v2\/posts\/117848\/revisions"}],"predecessor-version":[{"id":117849,"href":"https:\/\/www.tehnopol.ee\/en\/wp-json\/wp\/v2\/posts\/117848\/revisions\/117849"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.tehnopol.ee\/en\/wp-json\/wp\/v2\/media\/117012"}],"wp:attachment":[{"href":"https:\/\/www.tehnopol.ee\/en\/wp-json\/wp\/v2\/media?parent=117848"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.tehnopol.ee\/en\/wp-json\/wp\/v2\/categories?post=117848"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.tehnopol.ee\/en\/wp-json\/wp\/v2\/tags?post=117848"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}